MOUNTAINEER 188362045Recalls & reported problems
Medos International Sàrl · MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE 3.5 45mm · Class 2 · Implant
All models of MOUNTAINEER (51)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034158891), received between Feb 26, 2018 and Apr 27, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- Not Applicable2
- No Known Impact Or Consequence To Patient1
- Spinal Column Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2018Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION OF ONE (1) BROKEN OCCIPITAL PLATE DUE TO PAIN AND NONUNION ON (B)(6) 2018. THE PATIENT WAS IMPLANTED WITH THE OCCIPITAL PLATE, FOUR UNKNOWN SCREWS AND UNKNOWN QUANTITY OF UNKNOWN RODS (ALL DEPUY PARTS) WHILE UNDERGOING AN OCCIPITAL FUSION ON (B)(6) 2017. SUBSEQUENTLY, IN (B)(6) 2018 THE PATIENT COMPLAINED OF PAIN. A FOLLOW-UP X-RAY CONFIRMED THAT THE OCCIPITAL PLATE IMPLANTED EARLIER WAS BROKEN AND THAT THERE WAS A NONUNION; HENCE, ON (B)(6) 2018, THE BROKEN PLATE WAS REMOVED. PATIENT WAS REVISED TO A NEW SYNTHES PLATE (04.161.011). UNKNOWN SCREWS (QTY. 4) AND RODS.
Patient problems: Not Applicable; Spinal Column Injury
MAUDE report 7467853 ↗MalfunctionFeb 26, 2018Break; Break
OC PLATES BROKE WHILE BENDING. OC PLATE ROD CAPTURE WAS SPLAYED AND COULD NOT LOCK A SET SCREW. ADDITIONAL INFORMATION RECEIVED FROM REP: THE FIRST PLATE HAD THE ISSUE WITH THE SPLAYING OF THE RIGHT ROD CAPTURE (TULIP HEAD). THE 2ND AND 3RD PLATES WERE THEN BROKEN WHEN TRYING TO CONTOUR BECAUSE WE HAD TO REMOVE THE FIRST PLATE. SURGEON COMPLETED THE CASE, THE EVENT PROBABLY DELAYED THE CASE ABOUT 30 MINUTES. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES
Patient problems: No Known Impact Or Consequence To Patient; Not Applicable
MAUDE report 7297363 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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